Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
Not Applicable
Completed
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT01058746
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount.
Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental.
This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
Inclusion Criteria
- Adults > or = 18 years
- Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.
Exclusion Criteria
- Pregnancy
- History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal LV function within 30 days of operation
- MI within 3 months
- History of stroke
- History of congestive heart failure and ejection fraction less than 35%
- History of severe COPD and resting oxygen saturation (SpO2) < 90%
- Renal dysfunction (Cr > 1.8)
- Abnormal coagulation parameters (INR > 1.5 not on Coumadin, or platelet
- Presence of active infection including HIV
- BMI > 35
- American Society of Anesthesiologists Status > III, assigned at time of preoperative visit
- Corticosteroid use > 10 mg Prednisone/day
- Bilirubin > 10.0
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management. 3 years
- Secondary Outcome Measures
Name Time Method Determine if restrictive perioperative fluid management, comp to liberal periop fluid management, decreases delayed gastric emptying, length of stay (LOS) & the incidence of other, less frequent morbidity in adult patients getting pancreatic resection. 3 years
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center🇺🇸New York, New York, United States